Cervical Cancer Vaccine Shows Promise
Vaccine's Maker Plans to File for FDA Review by Year's End
Not Total Protection
The vaccine doesn't prevent all cervical cancer. Some cervical cancers are caused by other factors.
The vaccine would likely target women who haven't been exposed to HPV. The most likely candidates would be young women prior to the onset of sexual activity.
"At this point, there is no data suggesting that the vaccine works on women who already have the infection," National Cancer Institute epidemiologist Allan Hildesheim, PhD, tells WebMD.
It's not yet known how long the protection lasts, and if booster vaccines could extend the protection, says Hildesheim.
"It seems like a very important advancement to me, from what I've seen. There's limited information at this point. [But] it looks very promising," says Hildesheim.
"I think it has a good potential," says Lisa Flowers, MD, assistant professor of obstetrics and gynecology at Emory University's medical school.
"This is another exciting study which points to the likely availability of a vaccine for HPV, but it is critical [that] the data be peer-reviewed and published," states Debbie Saslow, PhD, in a statement emailed to WebMD.
Saslow is the director of breast and gynecological cancers for the American Cancer Society (ACS).
"If and when the FDA approves the vaccine, federal advisory groups will decide whether to recommend the vaccine and if so under what conditions (e.g.: at what age, etc.)," states Saslow.
The Gardasil phase III study participants were more than 12,000 women aged 16-26 years in 13 countries, states Merck's news release.
"In the U.S., most women will have been exposed (through sexual activity) to HPV by age 23 and many by age 16," states Saslow. "It is likely that the vaccine will be more effective if given to younger girls, before the onset of sexual activity, but we have very little data from this age group."
"While we have high rates of vaccination for infants and young children, it is more difficult to achieve wide participation in vaccination of older children and adolescents. This will be further complicated by the need for three doses," says Saslow.